(43 days)
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Not Found
No
The device description and intended use describe a physical restraint device with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a restraint used to prevent falls and slumping, not to treat a disease or condition.
No
The device description indicates it is a "jacket-style safety vest" intended to prevent patients from slumping, sliding, or falling, which are functions of a physical restraint, not a diagnostic tool.
No
The device description clearly describes a physical garment (jacket-style safety vest) made of materials like poly/cotton blend or polyester mesh, with physical components like straps, loops, Velcro fasteners, and a zipper. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Heelbo Blazer Sleeved Jacket is a physical restraint device designed to support and limit patient movement for safety purposes. It does not involve testing samples from the body.
The description clearly indicates it's a jacket-style safety vest used for physical support and restraint, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Heelbo Blazer Sleeved Jacket is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Blazer Sleeved Jacket is also intended to limit the patient's movement while lying in bed or on a gurney to prevent the patient from falling out of bed or climbing over the side rails.
Product codes
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Device Description
The Heelbo Blazer Sleeved Jacket is a jacket-style safety vest. The Heelbo Blazer Sleeved Jacket is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Blazer Sleeved Jacket is also intended to limit the patient's movement while lying in bed or on a gurney to prevent the patient from falling out of bed or climbing over the side rails.
The jacket has short sleeves and straps on each side of the vest that can be tied together to ensure a comfortable fit. The jacket is secured to a bed or wheelchair with two straps. There are also loops sewn to the shoulder area of the vest in the event extra support is needed. The jacket has Velcro® fasteners and a zipper in the back to ensure a secure fit as well as allowing for quick and easy release.
The Blazer Sleeved Jacket is available with a knotless system (quick disconnect option). This option allows the caregiver to quickly and easily disconnect the restraint from the chair or bed frame by eliminating time consuming untying of knots.
The Blazer Sleeved Jacket is available in a poly/cotton blend or a polyester mesh material. Five sizes accommodate a wide range of patients. The Blazer Sleeved Jacket is made of durable machine washable materials and is color coded for easy size identification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Caregiver
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Heelbo Blazer Sleeved Jacket
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
K 963243
Image /page/0/Picture/1 description: The image shows the text "Heelbo, Inc." in a bold, sans-serif font. The text is black and the background is white. The words are arranged on a single line, with a comma after "Heelbo" and "Inc." following.
1134 N. Homan Ave. Chicago, IL 60651
312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
OCT : ।
Heelbo, Inc. Blazer Sleeved Jacket
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
Submitter Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60651
Contact Person Joseph S. Tokarz; Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 (847)680-2849, Fax: (847)918-3860 Ph:
Date Summary Prepared - August 14, 1996
2. Name of Device:
Heelbo Blazer Sleeved Jacket
3. Name of Predicate Device(s)
Heelbo Blazer Sleeved Jacket
4. Description of Device
The Heelbo Blazer Sleeved Jacket is a jacket-style safety vest. The Heelbo Blazer Sleeved Jacket is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Blazer Sleeved Jacket is also intended to limit the patient's movement while lying in bed or on a gurney to prevent the patient from falling out of bed or climbing over the side rails.
The jacket has short sleeves and straps on each side of the vest that can be tied together to ensure a comfortable fit. The jacket is secured to a bed or wheelchair with two straps. There are also loops sewn to the shoulder area of the vest in the event extra support is needed. The jacket has Velcro® fasteners and a zipper in the back to ensure a secure fit as well as allowing for quick and easy release.
The Blazer Sleeved Jacket is available with a knotless system (quick disconnect option). This option allows the caregiver to quickly and easily disconnect the restraint from the chair or bed frame by eliminating time consuming untying of knots.
The Blazer Sleeved Jacket is available in a poly/cotton blend or a polyester mesh material. Five sizes accommodate a wide range of patients. The Blazer Sleeved Jacket is
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Image /page/1/Picture/0 description: The image shows the text "Heelbo, Inc." in a bold, sans-serif font. The text is black against a white background. The comma after "Heelbo" and the "Inc." are slightly smaller than the main word.
1134 N. Homan Ave. Chicago, IL 60651
312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo, Inc. Blazer Sleeved Jacket
The Blazer Sleeved Jacket is available in a poly/cotton blend or a polyester mesh material. Five sizes accommodate a wide range of patients. The Blazer Sleeved Jacket is made of durable machine washable materials and is color coded for easy size identification.
The chart below shows product availability:
| Series | Material | Size of Vest | Color |
|---|---|---|---|
| 9415 | |||
| 9415K | Poly/Cotton blend | x-small | White |
| small | Yellow | ||
| medium | Blue | ||
| large | Green | ||
| x-large | Beige | ||
| 9415B | |||
| 9415BK | Polyester Mesh material | x-small | White bias on white breezewear |
| small | Yellow bias on white breezewear | ||
| medium | Blue bias on white breezewear | ||
| large | Green bias on white breezewear | ||
| x-large | Beige bias on white breezewear |
The Blazer Sleeved Jacket Is Available in the Following Sizes and Configurations
5. Statement of Intended Use
The Heelbo Blazer Sleeved Jacket is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Blazer Sleeved Jacket is also intended to limit the patient's movement while lying in bed or on a gurney to prevent the patient from falling out of bed or climbing over the side rails.
6. Statement of Technological Characteristics of the Device
The Heelbo Blazer Sleeved Jacket is a jacket-style safety vest. The Heelbo Blazer Sleeved Jacket is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Blazer Sleeved Jacket is also intended to limit the patient's movement while lying in bed or on a gurney to prevent the patient from falling out of bed or climbing over the side rails.
2
Heelbo.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo, Inc. Blazer Sleeved Jacket
The jacket has short sleeves and straps on each side of the vest that can be tied together to ensure a comfortable fit. The jacket is secured to a bed or wheelchair with two straps. There are also loops sewn to the shoulder area of the vest in the event extra support is needed. The jacket has Velcro® fasteners and a zipper in the back to ensure a secure fit as well as allowing for quick and easy release.
The Blazer Sleeved Jacket is available with a knotless system (quick disconnect option). This option allows the caregiver to quickly and easily disconnect the restraint from the chair or bed frame by eliminating time consuming untying of knots.
The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification. The only difference is that the product labeling has been revised to comply with the Agency's labeling requirements set forth in the draft "Guidance on the Content of Premarket Notification [501(k)] Submissions for Protective Restraints" dated December 1995.
7. Biocompatibility
The subject devices are identical in component materials to the predicate devices. The suppliers of the materials use in the fabrication of these devices have stated that there is a history of safe use of their materials in the clothing and garment industry. In addition, Heelbo, Inc., is not aware of any reports or complaints of skin irritation associated with these materials.
8. Conclusion
Based upon the information presented above it is concluded that the proposed Heelbo Blazer Sleeved Jacket is safe and effective for its intended use and is substantially equivalent to the predicate device.